罗红霉素注射液的热稳定性研究  

Study on the Thermal Stability of Roxithromycin Injection

作　　者：唐燕[1] 罗永煌[1] 程千川 李竞[1] 周廷宜[1] 

机构地区：[1]西南大学药学院,重庆400716 [2]重庆市饲料兽药监察所,重庆400015

出　　处：《海峡药学》2006年第4期64-67,共4页Strait Pharmaceutical Journal

基　　金：重庆市教委科学技术研究项目(030211)

摘　　要：目的考察经羟丙基-β-环糊精和γ-环糊精包合罗红霉素制备出的注射液Ⅰ和Ⅱ的热稳定性,初步筛选出适合临床应用的罗红霉素注射液。方法研磨法制备包合物,HPLC测定罗红霉素注射液Ⅰ和Ⅱ经不同温度处理后的含量,以初均速法预测其有效期。结果罗红霉素注射液Ⅰt0.925℃=1.8a;罗红霉素注射液Ⅱt0.925℃=0.87a。结论由羟丙基-β-环糊精包合罗红霉素所制备的注射液,有效期可达1.8年,基本可以满足临床应用。OBJECTIVE Roxithromycin injection, suitable for clinical application was selected by assessing the thermal stability of roxithromycin injection I and roxhhromycin, injection Ⅱ,which were respectively wraped by hydroxypropyl-β-cyclodextrin and γ-cyclodextrin. METHODS The inclusion compounds were prepared by trituration method. A reversed-phase HPLC method was developed for the determination of contents in roxithromycin injection I and roxithromycin injection Ⅱ at different temperture and time. Initial equal-speed method was adopted to predict the period of validity. RESULTS Periods of validity for roxithromycin injection I is t0.9^25℃ = 1.8a,and t0.9^25℃= 0. 87a for roxithromycin injection Ⅱ . CONCLUSION Roxithromycin injection Ⅰ wraped by hydroxypropyl-β-cyclodextrin could be stored for 1.8 year at room temperature. It is suitable for clinical application.

关 键 词：罗红霉素注射液 热稳定性 有效期 高效液相色谱法 初均速法 羟丙基-Β-环糊精 Γ-环糊精 

分 类 号：R927.11[医药卫生—药学]